Cushing's disease demands a structured, evidence-based approach guided by specific clinical goals. The protocol establishes a clear first-line intervention, defines the expertise and centre requirements for that intervention, and sets the remission criteria that determine success.
Pituitary surgery is the established first-line treatment, and the protocol specifies precise requirements around surgical expertise and the type of centre where the procedure should be performed. The complete regimen — including the specific procedure, centre criteria, and care team composition — is in the full protocol.
The primary endpoint is biochemical remission, confirmed through post-operative serum cortisol measurement against a defined threshold. The protocol specifies this threshold and the monitoring schedule used to verify it.
DOI: 10.1016/S2213-8587(21)00235-7